We are NeuroVasc Technologies! We deliver excellence through innovation with integrity.

Our Principal R&D Engineer will be responsible for designing, developing, and qualifying prototypes, processes, and equipment for medical device manufacturing while performing inspections, assembly, and pre-clinical testing for medical device qualification by performing the following duties.

Duties and Responsibilities include the following. Other duties may be assigned.

1. Designs and develops medical devices from concept through commercialization.*
2. Creates design documents including drawings, specifications, protocols, reports, and procedures.*
3. Supervises laboratory facilities, operations and maintenance.*
4. Develops and qualifies processes and manufacturing procedures, including equipment qualification.*
5. Creates, validates, and releases test methods, including sourcing equipment for measurements.*
6. Designs and creates test models for development and qualification of devices.*
7. Supervises and performs pre-clinical testing, including in vivo testing.*
8. Maintains a safe work environment while working with chemicals and hazardous materials.*
9. Assists in creating systems for design, development, qualification, calibration, maintenance, and manufacturing.*
10. Creates calibration and inspection procedures, executes, and documents procedures.*
11. Prototypes and develops medical devices from concept to commercialization.*
12. Designs, creates, sources, builds, calibrates, qualifies, and maintains equipment used to manufacture and prototype devices.*
13. Works with users to determine user needs and translates these into specifications.*
14. Identifies, collaborates with, and qualifies vendors for device components and supplies.*
15. Performs and documents risk management activites.*
16. Defines and coordinates testing with outside test laboratories, including pre-clinical test labs.*
17. Assists in quality and regulatory system creation and implementation.*
18. Plans subprojects, communicates plans, tracks and communicates progress, maintains accountability, and provides updates to management and the team.*
19. Supports users and clinical work in the field, including field representative and customer training.*

Education/Experience:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, or related engineering degree.
• Minimum of seven years of experience in medical device mechanical design.
• Experience in design and manufacturability of catheter-based, endovascular devices with a variety of materials including plastics and alloys.
• In-depth knowledge of Design Control requirements and experience generating documentation including Part Qualification Plan, Design Requirements, Risk Management, Design Verification and Validation.
• Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).

Preferred Qualifications / Specialized Training:

• Experience with development and manufacturing of Neurovascular devices
• Experience in medical device manufacturing line support
• Experience with laser cutting, braiding and implant design
• Experience with delivery system design
• Experience with catheter design, construction and manufacturing
• Project Management

Salary Range 150-190K, depending on experience

NeuroVasc is an equal opportunity employer.